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IMDELLTRA (TARLATAMAB-DLLE)
IMDELLTRA (generic name: TARLATAMAB-DLLE) is a drug developed by AMGEN INC. It is currently FDA-approved.
IMDELLTRA, also known as Tarlatamab, is a T cell surface glycoprotein CD3 binding agent used in the treatment of small cell lung cancer. It is an antibody-based treatment being studied in phase 2 clinical trials for various small cell lung cancer indications, including relapsed/refractory and limited-stage disease.
At a glance
| Generic name | TARLATAMAB-DLLE |
|---|---|
| Sponsor | AMGEN INC |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving IMDELLTRA. Initiate IMDELLTRA using the step-up dosing schedule to reduce the incidence and severity of CRS. Withhold IMDELLTRA until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.5) and Warnings and Precautions (5.1) ] . Neurologic toxicity and immune effector cell-associated neurotoxicity syndrome (ICANS), including life-threatening or fatal reactions, can occur in patients receiving IMDELLTRA. Monitor patients for signs and symptoms of neurologic toxicity, including ICANS, during treatment and treat promptly. Withhold IMDELLTRA until ICANS resolves or permanently discontinue based on severity [see Dosage and Administration (2.5) and Warnings and Precautions (5.2) ] . WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME See full prescribing information for complete boxed warning . Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving IMDELLTRA. Initiate treatment with the IMDELLTRA using step-up dosing schedule to reduce the incidence and severity of CRS. Withhold IMDELLTRA until CRS resolves or permanently discontinue based on severity. ( 2.5 , 5.1 ) Neurologic toxicity and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), including life-threatening or fatal reactions, can occur in patients receiving IMDELLTRA. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment and treat promptly. Withhold IMDELLTRA until ICANS resolves or permanently discontinue based on severity. ( 2.5 , 5.2 )
Common side effects
- Cytokine Release Syndrome (CRS)
- Fatigue
- Decreased Appetite
- Dysgeusia
- Pyrexia
- Constipation
- Musculoskeletal Pain
- Nausea
- Decreased Lymphocytes
- Decreased Sodium
- Decreased Total Neutrophils
- Increased Uric Acid
Serious adverse events
- Serious Adverse Reactions (Overall)
- Cytokine Release Syndrome (CRS)
- Pyrexia
- Pneumonia
- Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
- Cardio-respiratory Arrest
- Sepsis
- Fatal ICANS
Key clinical trials
- A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311) (Phase 1)
- A Phase 3, Open Label, Multicenter, Randomized Study of First Line Tarlatamab in Combination With Durvalumab, Carboplatin and Etoposide Versus Durvalumab, Carboplatin and Etoposide in Untreated Extens (Phase 3)
- A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of Tarlatamab in Subjects With Relapsed/Refractory Small Cell Lung Cancer After Two or More Prior Lines of Treatment (Phase 2)
- A Front-Line Window-of-Opportunity Phase 2 Study of Tarlatamab (Bispecific T Cell Engager: DLL3-CD3) in Patients With Extensive-Stage Small-Cell Lung Cancer (Phase 2)
- A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of Subcutaneous Tarlatamab in Subjects With Extensive Stage Small Cell Lung Cancer (DeLLphi- (Phase 1)
- A Phase II Clinical Trial of Tarlatamab as Maintenance Treatment After Sequential Chemo-radiotherapy for Limited Stage SCLC Patients Not Eligible for Concurrent Chemo-radiotherapy (Phase 2)
- Phase 2a Study Evaluating the Efficacy, Safety, Tolerability and Pharmacokinetics of Tarlatamab in Chinese Subjects With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment (DeL (Phase 2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- IMDELLTRA CI brief — competitive landscape report
- IMDELLTRA updates RSS · CI watch RSS
- AMGEN INC portfolio CI
Frequently asked questions about IMDELLTRA
What is IMDELLTRA?
IMDELLTRA (TARLATAMAB-DLLE) is a pharmaceutical drug developed by AMGEN INC.
Who makes IMDELLTRA?
IMDELLTRA is developed and marketed by AMGEN INC (see full AMGEN INC pipeline at /company/amgen).
What is the generic name of IMDELLTRA?
TARLATAMAB-DLLE is the generic (nonproprietary) name of IMDELLTRA.
What development phase is IMDELLTRA in?
IMDELLTRA is FDA-approved (marketed).
What are the side effects of IMDELLTRA?
Common side effects of IMDELLTRA include Cytokine Release Syndrome (CRS), Fatigue, Decreased Appetite, Dysgeusia, Pyrexia, Constipation. Serious adverse events: Serious Adverse Reactions (Overall), Cytokine Release Syndrome (CRS), Pyrexia, Pneumonia.
Related
- Manufacturer: AMGEN INC — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing